oasis next gen project ncr management - pri … · (inpa) with membership from the americas, europe...
TRANSCRIPT
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
OASIS Next Gen Project
NCR Management
March 31, 2017
V3
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
2
Instructions
• This guidance material was created to provide userinstructions for the creation and management of theon-line Non Conformance Report (NCR) report withinthe OASIS database, including:– High Level Path - process flow
– AQMS Auditor Steps• NCR generation
• Response review
• Acceptance
– Supplier Organization Steps• Acknowledgement
• Corrective action input
– NCR Notification• Step by Step instructions
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
3
OASIS Next Gen NCR Management(Form 4)
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
4
OASIS Next Gen NCR Management(High-Level Path)
NCR ManagementNCR Management
CB
Au
dit
En
try A
dm
inC
B A
ud
it E
ntr
y A
dm
inA
ud
ito
rA
ud
ito
rS
up
pli
er
Rep
rese
nta
tive
Su
pp
lier
Rep
rese
nta
tive
Lead
Au
dit
or
Lead
Au
dit
or
Audit Set-up
OK?RejectAccess Audit
Number
Enter details, define
Due Date and Sign-off
(NCR Opened)
STEP 1 STEP 2 STEP 3 STEP 4 STEP 5 STEP 6
Access Audit
Number
Aknowledge and
Sign-off
receipt of NCR
Review of
Organization
Planned Actions
Define & Submit
Organization
Planned Actions
and Sign-off
Accepted &
Sign-off
Verification and
NCR Closure
Verification and
NCR Closure
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
5
AQMS Auditor Steps
After logging in to
OASIS, click
“Manage Audits”
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
6
Select Status:
“New WIP” or “Any”Then click “Search”
AQMS Auditor Steps
Work in Process (WIP)
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
7
Click on applicable
audit reference number
AQMS Auditor Steps
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
8
In conjunction with other
audit package entries,
click Form 4 arrow
Then click “Add New”
AQMS Auditor Steps
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
9
Click “Import” to select
and upload supplier
site information
Enter Section 1
Nonconformity Details
Add discussion data
and notes as applicable
AQMS Auditor Steps
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
10
Click “Add New” to add
Discussion and Notes
AQMS Auditor Steps
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
11
Click to add attachment
Enter Subject and
message details
AQMS Auditor Steps
Click “Add Row” to add
other attachment(s)
Click “Post” to publish
Discussion
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
12
Click to add attachment
Enter Subject and
message details
AQMS Auditor Steps
Click “+Add Row” to add
other attachment(s)
Click “Post” to publish
Discussion
Click “x” to remove
attachment(s)
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
13
AQMS Auditor Steps
Posted discussion and Note
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
14
Then click to sign for
Section 1 entries
AQMS Auditor Steps
Click to save changes
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
15
Supplier Organization Steps
Click on applicable
audit reference number
Select Status:
“New WIP” or “Any”Then click “Search”
After logging in to
OASIS, click
“Manage Audits”
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
16
Supplier Organization Steps
Click on applicable
audit reference number
Select Status:
“New WIP” or “Any”Then click “Search”
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
17
Supplier Organization Steps
Click on applicable
audit reference number
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
18
Supplier Organization Steps
Click Form 4 arrowThen click applicable
NCR number
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
19
Supplier Organization Steps
Click to view and enter
discussion data and notes
as applicable
View nonconformity
details
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
20
Supplier Organization Steps
Click to access designated
organizational representative
name(s)
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
21
Select organizational
representative name
from drop-down list
Enter NCR receipt date
Click to save entry
acknowledging receipt
of NCR
Supplier Organization Steps
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
22
Supplier Organization Steps
Enter Section 2
planned action details
and dates
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
23
Supplier Organization Steps
Click to add attachments
as applicable
Click to save data entries
After saving data, click to
access designated
organizational representative
name(s)
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
24
Supplier Organization Steps
Select organizational
representative name
from drop-down list
Enter Section 2
completion date
Click to save entry
acknowledging completion
of Section 2
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
25
AQMS Auditor Steps
After logging in to
OASIS, click
“Manage Audits”
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
26
Select Status:
“New WIP” or “Any”Then click “Search”
AQMS Auditor Steps
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
27
Click on applicable
audit reference number
AQMS Auditor Steps
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
28
Click Form 4 arrowThen click applicable
NCR number
AQMS Auditor Steps
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
29
Review Section 2 informationClick to add attachment
as applicable
Click applicable button to either
sign (accept) or reject
Section 2 information
AQMS Auditor Steps
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
30
Supplier Organization Steps
Click on applicable
audit reference number
Select Status:
“New WIP” or “Any”Then click “Search”
After logging in to
OASIS, click
“Manage Audits”
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
31
Supplier Organization Steps
Click on applicable
audit reference number
Select Status:
“New WIP” or “Any”Then click “Search”
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
32
Supplier Organization Steps
Click on applicable
audit reference number
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
33
Supplier Organization Steps
Click Form 4 arrowThen click applicable
NCR number
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
34
Supplier Organization Steps(With Rejected Stage 2 Response)
Review rejection reason
Click to access designated
organizational representative
name(s)
Add attachment
as applicable
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
35
Supplier Organization Steps(With Rejected Stage 2 Response)
Click to edit planned actions
Click to save changes
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
36
AQMS Auditor Steps
After logging in to
OASIS, click
“Manage Audits”
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
37
Select Status:
“New WIP” or “Any”Then click “Search”
AQMS Auditor Steps
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
38
Click on applicable
audit reference number
AQMS Auditor Steps
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
39
Click Form 4 arrowThen click applicable
NCR number
AQMS Auditor Steps
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
40
Review Section 2 informationClick to add attachment
as applicable
Click applicable button to either
sign (accept) or reject
Section 2 information
AQMS Auditor Steps
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
41
Enter verification details
AQMS Auditor Steps
Click to access
auditor name(s)
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
42
Enter NCR closure date
AQMS Auditor Steps
Check applicable
auditor name(s)
Click to add name(s)
and date to Section 3
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
43
AQMS Auditor Steps
Audit team leader
click to access name
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
44
Enter NCR closure date
AQMS Lead Auditor Steps
Check lead auditor name
Click to add name
and date to Section 3
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
45
AQMS Lead Auditor Steps
Lead auditor Section 3
acceptance updates
NCR status to “Closed”
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
46
The management of NCRs raised during the auditprocess is associated with a series of emailnotifications that are automatically generated bythe OASIS database system.
Email notifications are sent to user roles/events foreach of the steps identified in the NCR Form 4 (seenext slide) when an NCR is generated.
Each of the events that trigger the emailnotification, will also log the applicable informationor each event.
NCR events are tracked in a way they can later beused for Supplier Advisories.
NCR's Notifications
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
47
NCR's Notifications
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
48
CB
Audit
Entry
Admin
Supplier
RepAuditor
Lead
Auditor
Auditor completes Form 4
(NCR) and confirms it is done
by signing off (Auditor).
16 No Y Y Y
If Auditor or CB modifies
Section 1 after it is submitted
to the supplier.
No Y Y Y
2
Supplier Rep Acknowledge
receipt of NCR report
(Organisation Representative)
17 No Y Y Y
3
Supplier Rep Submits
"Organizations Planned
Actions" for review by auditor
by filling in applicable fields
and signing off (Organisation
Representative)
28 No Y Y Y
Notification Goes To
NotesSteps EventForm
Box #
1
NCR's Notifications
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
49
CB
Audit
Entry
Admin
Supplier
RepAuditor
Lead
Auditor
Auditor accepts the actions
documented in Form 4 -
SECTION 2 – ORGANISATION’S
PLANNED ACTIONS and signs
off on acceptance (Auditor
Acceptance)
29 No Y Y Y
Auditor rejects the actions
documented in Form 4 -
SECTION 2 – ORGANISATION’S
PLANNED ACTIONS
Clears the previous step3 No Y Y Y
Containment Action Planned
Completion Date exceeded
OASIS will send a daily
containment action reminder if
1 - Form 4 box #14
containment required is
identified as "yes"
2 - Form 4 box #21 planned
completion date is exceeded
AND the actual completion
date Form 4 box #22 is not
filled in.
Y Y Y Y
Corrective Action Planned
Completion Date exceeded
OASIS will send a daily
corrective action reminder if
1 - Form 4 "#26 planned
completion date" is exceeded
AND the actual completion
date Form 4 box #27 is not
filled in.
Y Y Y Y
Ready for Auditor verification
Ready means the Actual
Completion Date Form 4 box
#27 for the Corrective Action
has been entered.
No Y Y Y
NotesSteps EventForm
Box #
Notification Goes To
4
NCR's Notifications
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
50
CB
Audit
Entry
Admin
Supplier
RepAuditor
Lead
Auditor
If Originating auditor
approves and signs off
(Auditor Acceptance)
29 No Y Y Y
If Originating auditor rejects Need to enter "reason for
rejection"No Y Y Y
If Auditor or CB modifies
Section 2 after it is submitted
to the supplier
No Y Y Y
Lead auditor approves and
signs off the NCR is complete
(Audit Team Leader)
32 No Y Y Y
Lead auditor rejects NCR
completeness 32
Ned to enter "reason for
rejection"No Y Y Y
NotesSteps EventForm
Box #
Notification Goes To
5
6
NCR's Notifications
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
51
Discussion
Originator
CB
Audit
Entry
Admin
Supplier
RepAuditor
Lead
Auditor
Discussions and responses to
discussionsY No Y Y Y
Attachments Adding an attachment to an
NCRNo No Y Y Y
Auditor Deletes an NCR before
it is assigned to a supplier for
review/action
The status is WIP.. No No No No No
Auditor changes the status to
something such that it is no
longer an NCR (cancelled,
changed to an observation,
changed to improvement)
Requires a reason for change Y No Y Y Y
Notes
Notification Goes To
Steps EventForm
Box #
Misc
NCR's Notifications